Stryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach
Stryker Instruments is voluntarily recalling 225 Sagittal Blades due to a potential sterile barrier breach in the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a potential packaging defect (sterile barrier breach) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling 225 units of the Sagittal Blade 18.0X0.97X90MM, Model Number 6118-097-090. The recall is being conducted due to the potential for a sterile barrier breach in the product's packaging.
These heavy-duty blades are used to cut bone and bone-related tissue in orthopedic procedures, including total-knee, uni-compartmental knee, hip, shoulder, and ankle surgeries. The affected units are distributed nationwide in the United States in the states of Rhode Island, Washington, California, Colorado, Wisconsin, Florida, Idaho, North Dakota, Maryland, and Texas. The products were also distributed in Australia, New Zealand, the Netherlands, France, and Italy.
The source text does not specify the exact actions consumers or healthcare providers should take beyond the voluntary recall status. The agency classification for this recall is Class II.
The recalled product
- Product
- Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 225
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Sagittal Blade 18.0X0.97X90MM
- Model Number: 6118-097-090
- Lot # 16029017
Distribution
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